Results demonstrate strong safety and efficacy for NVK002 as a potential treatment for  

       the  progression of myopia in children

       NVK002 displays strong potential to improve the quality of life for the millions of 

       children in  China currently suffering from myopia

HONG KONG, 13 October 2023 – Zhaoke Ophthalmology Limited (“Zhaoke Ophthalmology” or the “Company”, SEHK: 6622), a leading ophthalmic pharmaceutical company dedicated to the research and development, manufacturing and commercialization of therapies that address significant unmet medical needs, is pleased to announce the top-line results from its one-year Phase III clinical trial (“Mini-CHAMP”) of one of the Company’s core products, NVK002.

Analysis of this multi-center study, performed after one year of treatment, demonstrates strong safety and efficacy for NVK002 as a potential treatment for the progression of myopia in children, and indicates consistent trends with the Phase III CHAMP clinical study performed by the Company’s US partner, Vyluma, Inc. (“Vyluma”) during its first year. 

Dr. Li Xiaoyi (Benjamin), Chairman and CEO of Zhaoke Ophthalmology, said, “We are encouraged by the positive results from our mini-CHAMP trial of NVK002. In China, hundreds of millions of children and adolescents are currently suffering from myopia. We are eager to do our part to offer a safe, effective and convenient solution to these patients and their families across the region as soon as possible. The trial results represent a major milestone and put us one step closer to launching an innovative drug for slowing myopia progression in China.”

Phase III Mini-CHAMP is a randomized, double-masked, placebo-controlled, multi-center clinical study. The main objective is to evaluate the efficacy and safety of NVK002 in slowing the progression of myopia in children and adolescents in China. The trial involved 16 centers and enrolled 526 children and adolescents. It was co-led by Professor Qu Xiao Mei from Eye & ENT Hospital of Fudan University, and Professor Yang Xiao from Zhongshan Ophthalmic Center, Sun Yat-Sen University, as the Principal Investigators.

Mini-CHAMP successfully met its primary efficacy endpoint with both doses of 0.01% and 0.02% NVK002 achieving statistically and clinically meaningful differences versus placebo in terms of slowing myopia progress in the study population. NVK002 at both doses were well tolerated and safe as reflected by the low treatment discontinuation rates and low ocular serious adverse events (SAEs) respectively. 

Zhaoke Ophthalmology plans to communicate with regulatory authorities to advance the process of New Drug Application (“NDA”) for NVK002 in China combining the results from Mini-CHAMP with the data from Vyluma’s Phase III CHAMP study.

Dr. Albert Tsai, Chief Medical Officer of Zhaoke Ophthalmology, said, “I am very proud of the positive results from our Mini-CHAMP trial of NVK002. They are the achievement of a highly skilled and dedicated team who overcame a number of challenges during the trial period. Patient enrollment was completed significantly ahead of schedule despite delays at the beginning of the study caused by COVID-19, and the trial itself was conducted with an exceptionally high standard of quality. Our work now turns to combining the results from our China trial with those from our partner Vyluma’s US trial in preparation for submitting a formal New Drug Application to the Chinese regulator.”

Raul Trillo, MD, MBA, President & Chief Commercial Officer of Vyluma, said, “We are pleased and encouraged by the significant progress made by Zhaoke Ophthalmology, our key partner in China and Southeast Asia. With the significant number of children and adolescents with myopia in the region, we continue to see China and Southeast Asia as an important and integral part of the global opportunity for NVK002. We look forward to Zhaoke Ophthalmology's continued progress.”

On October 11, 2023, Vyluma announced positive top-line results from the second stage of its Phase III CHAMP clinical study NVK002. Analysis of the results of this multi-center, international study conducted after four years of treatment and follow up, show continued strong safety, the absence of rebound upon washout of the study drug, and continued efficacy for NVK002 as a potential treatment for myopia in children.

Alongside the one-year Mini-CHAMP study, Zhaoke Ophthalmology has been conducting a parallel two-year Phase III clinical trial (“China CHAMP”). The China CHAMP trial involved 18 centers and enrolled 777 patients. Patient enrollment was completed on July 21, 2022.

About NVK002

NVK002 is an investigational novel topical ophthalmic solution to control myopia progression in children and adolescents. NVK002 has a proprietary formulation that successfully addresses the instability of low-concentration atropine, this technology has intellectual property protection globally. It is preservative-free with an expected shelf life of at least 24 months. According to information from China Insights Consultancy (“CIC”), NVK002 is currently one of the most advanced atropine drug candidates globally for treating myopia progression, and targets the broadest patient group, covering children and adolescents from 3 to 17 years old. The clinical development of NVK002 involves two different concentrations of atropine to allow flexibility in achieving maximal efficacy and minimal adverse effects for tailoring to the needs of individual patients.

About the License Agreement with Vyluma, Inc.

In October 2020, the Company entered into a license agreement, namely the NVK002 License Agreement, with Nevakar Inc., which later assigned the agreement to its wholly-owned subsidiary, Vyluma Inc. for an exclusive license to develop, manufacture, register, import and commercialize NVK002 in Greater China, South Korea and certain countries in Southeast Asia (including Brunei, Burma, Cambodia, Timor-Leste, Indonesia, Laos, Malaysia, the Philippines, Singapore, Thailand and Vietnam). For details of the license agreement in relation to NVK002, please refer to “Business – Collaboration and License Agreements – License of NVK002” of the prospectus of the Company dated April 16, 2021.

About Vyluma, Inc.

Vyluma is a development-stage biopharmaceutical company with a focus on pharmaceutical treatments for refractive errors of the eye. Vyluma has a robust pipeline of assets in various stages of development which address important unmet treatment needs of patients with refractive errors or eye pain. Vyluma is a subsidiary of Nevakar Inc., a holding company whose subsidiaries are also engaged in developing products for the injectable markets. For additional information regarding NVK002 or Vyluma please visit www.vyluma.com.